Clinical Trial: Incidence of Second Primary Malignancies in Castration-Resistant Prostate Cancer: An Observational Retrospective Cohort Study in the US

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

Official Title: Incidence of Second Primary Malignancies in Patients With Castration-Resistant Prostate Cancer: An Observational Retrospective Cohort Study in the US

Brief Summary:

This study is conducted to estimate population-based incidence rates of second primary malignancies among patients with CRPC similar to those treated with Xofigo. These rates will provide context for second primary malignancy incidence rates from the REASSURE study.

Furthermore this study aims to provide further information about the documentation of bone metastases in Medicare data and the extent of use of only oral androgen deprivation drugs among patients with Medicare Part D coverage, as well as to estimate overall survival of the study population.


Detailed Summary:

Xofigo (radium-223 dichloride) is an alpha-emitting pharmaceutical, which was approved for the treatment of patients with castration-resistant prostate cancer (CRPC), symptomatic bone metastases, and no known visceral metastatic disease. The long-term safety profile of Xofigo is evaluated in the prospective REASSURE study, which estimates the incidence rates of second primary malignancies in patients with CRPC receiving Xofigo.

To provide context on that, this retrospective study is conducted to estimate background rates of second primary malignancies among patients with CRPC similar to those who are treated with Xofigo.


Sponsor: Bayer

Current Primary Outcome:

  • Estimation of the collective incidence rate of all second primary malignancies (other than nonmelanoma skin cancer) among men with CRPC (Castration-Resistant Prostate Cancer) [ Time Frame: 8 year data period ]
  • Estimation of the individual incidence rates of selected second primary malignancies [ Time Frame: 8 year data period ]


Original Primary Outcome:

  • Estimation of the collective incidence rate of all second primary malignancies (other than nonmelanoma skin cancer) among men with CRPC (Castration-Resistant Prostate Cancer) [ Time Frame: 8 year data period ]
  • Estimation the individual incidence rates of selected second primary malignancies [ Time Frame: 8 year data period ]


Current Secondary Outcome:

  • Estimation of the proportion of men with CRPC who have a diagnostic code for bone metastases in their Medicare claims before development of CRPC [ Time Frame: 8 year data period ]
  • Estimation of the proportion of men with CRPC who have received bone-directed therapies before development of CRPC [ Time Frame: 8 year data period ]
  • Estimation of the proportion of men with CRPC and Medicare Part D coverage who received only oral androgen deprivation therapy [ Time Frame: 8 year data period ]
  • Estimation of overall survival of men with CRPC [ Time Frame: 8 year data period ]


Original Secondary Outcome: Same as current

Information By: Bayer

Dates:
Date Received: May 27, 2016
Date Started: May 2016
Date Completion: March 2017
Last Updated: February 6, 2017
Last Verified: January 2017